Assessment of Cosmetic Product Safety and Responsibilities of the Responsible Person (RP)

Key Compliance Requirements for the Cosmetic Product Safety Report (CPSR):

• Product Information:
  • Ensure that the product name, type, or formulation listed in the CPSR matches the product under inspection.
• Annex I Compliance:
  • All sections of Annex I of the UK Cosmetics Regulation must be included in the CPSR.
• Safety Assessor Credentials:
  • The safety assessor must meet the requirements of Article 10, including formal qualifications in relevant scientific disciplines.
• Ingredients Listing:
  • Provide a comprehensive list of ingredients, including:
    • Chemical names.
    • CAS numbers.
    • Concentrations (must total 100%).
  • Each ingredient should have a detailed function.
  • List colorants, preservatives, or UV filters as per Annex IV, V, and VI.
• Testing and Justifications:
  • Include references to stability testing, the Preservative Challenge Test, and microbiological testing, or provide plausible justifications if not conducted.
• Packaging Information:
  • Provide technical information about packaging materials, ensuring compatibility and design safety.
  • Justify durability assessment, Best Before End date, or Period After Opening.
• Exposure Assessment:
  • The safety assessor should perform an exposure assessment relevant to the product type, considering:
    • Use patterns.
    • Application site.
    • Exposure routes.
• Toxicological Profile:
  • Reference each ingredient’s toxicological profile, including unavoidable impurities and their justification for consumer safety.
• Mandatory Warnings:
  • Issue specific warnings for ingredients with mandatory warnings as specified in the Annexes.
• Report Updates:
  • Ensure the CPSR is up to date, reflecting new scientific research, ingredient restrictions/prohibitions, or post-market surveillance data.
• Consistency:
  • Maintain consistency in RP or manufacturer details throughout the report.

Checklist for Responsible Persons:

Verify that the CPSR is comprehensive and complies with legal requirements by ensuring all the above points are addressed.

Source: “https://www.ctpa.org.uk/news/important-non-compliant-cpsrs-in-the-uk-7867
https://www.ctpa.org.uk/file.php?fileid=4589“

Region: European Union, United Kingdom